Phase 3 Oesophageal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 or older, of any gender
• People who are willing to take part and able to sign a consent form agreeing to join the study
• People whose general health and activity level is rated as 0 or 1 on a standard oncology scale (meaning fully active or able to carry out light work), measured within 7 days before the first dose
• People whose estimated life expectancy is more than 3 months
• Women who could potentially become pregnant must have a negative blood pregnancy test within 7 days before being assigned to a treatment group, and must not be breastfeeding at the time of joining
• All participants, and their partners, must use reliable barrier contraception throughout the entire treatment period and for 6 months after treatment ends
• People who are able to understand what the trial involves and are willing and able to follow all trial procedures and attend follow-up appointments
• People whose side effects from any previous cancer treatment have mostly resolved, rated at a mild level or lower on a standard side effect scale (NCI-CTCAE version 6.0, grade 1 or below)
• People who have been confirmed by tissue or cell testing to have unresectable (cannot be surgically removed) locally advanced or metastatic esophageal squamous cell carcinoma (a specific type of oesophageal cancer), staged according to a standard cancer staging system (AJCC 8th edition)
• People who have at least one measurable area of cancer that can be tracked on scans, according to standard measurement guidelines (RECIST v1.1)
• People with adequate bone marrow and organ function (confirm with trial site for specific thresholds)

Who may not be able to join:

• People who have been diagnosed with another separate primary cancer within the past 5 years
• People whose cancer has been confirmed to be the adenosquamous carcinoma subtype of oesophageal cancer
• People who have cancer that has spread to the brain, unless it is causing no symptoms and imaging taken at least 4 weeks before joining has confirmed it has not been growing
• People who have cancer that has spread to the thin membranes surrounding the brain and spinal cord, or to the brainstem
• People who have spinal cord compression detected on imaging, regardless of whether it is causing symptoms
• People who have previously received or are currently receiving a type of cancer treatment known as topoisomerase I inhibitors
• People who have previously received any cancer therapy that specifically targets a protein called B7-H3
• People whose cancer has already progressed on, or who cannot tolerate, the chemotherapy treatments used in the control group of this trial
• People who have not waited long enough after finishing previous cancer treatments before joining the trial (confirm with trial site for specific timeframes)
• People who have had major surgery (not including biopsies) or a significant injury within 4 weeks before joining
• People who are expected to need planned surgery during the study period
• People who have received a live or live-attenuated vaccine within 4 weeks before being assigned to a treatment group
• People who have been taking steroid medicines (such as prednisone at more than 10 mg per day, or an equivalent dose of a similar medicine) or other immune-suppressing medications within 14 days before joining
• People with moderate to severe lung disease that significantly affects how well the lungs work, including conditions such as idiopathic pulmonary fibrosis, autoimmune or connective tissue disorders affecting the lungs, or those who have had a lung surgically removed
• People who have a history of a lung condition called interstitial lung disease or non-infectious pneumonitis that required steroid treatment, who currently have this condition, or where this condition cannot be ruled out based on screening scans
• People with active tuberculosis
• People with autoimmune diseases that are not currently in remission, or other immune deficiency conditions (whether inherited or acquired)
• People who have previously had a stem cell, bone marrow, or organ transplant from another person
• People who had a serious infection (such as bacteria in the bloodstream or severe pneumonia) within 4 weeks before joining
• People who have had an active infection requiring antibiotic treatment taken throughout the body within 1 week before joining
• People with positive results on certain virus blood tests (note: people with hepatitis B who are receiving antiviral treatment, other than interferon, may still be considered eligible — confirm with trial site)
• People with uncontrolled or significant heart or blood vessel disease
• People with fluid build-up in body cavities (such as around the lungs or abdomen) that is not being adequately controlled
• People with a known allergy or serious sensitivity to any of the study drugs or closely related medicines (such as docetaxel, paclitaxel, or irinotecan hydrochloride)
• People with a history of alcohol or drug dependence or abuse
• People who the trial doctor considers unlikely to follow the trial requirements reliably
• People with a history of other serious systemic (whole-body) diseases
• People with any other medical condition that the trial doctor believes could interfere with participation or affect the trial results

Important: Always verify eligibility with the trial site directly before applying.